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The FDA has called on manufacturers of ENFit low-dose tip (LDT) syringes to update their labeling to reduce the risk that their products will lead to accidental overdoses. Read More
The FDA is trying to address barriers to more widespread use of over-the-counter (OTC) hearing aids, including cost, access and state and federal regulations, through a proposed rule and draft guidance published today in the Federal Register. Read More
It can be faster in some cases to make use of the FDA’s 510(k) marketing clearance pathway than to apply for Emergency Use Authorization (EUA), a medical device regulatory consultant says. Read More
Marlborough, Mass.-based obstetrics-gynecological device company, Hologic, is expanding its portfolio of laparoscopic devices through a $160 million purchase of Bolder Surgical, a privately held company in Louisville, Colo., that specializes in vessel-sealing surgical devices. Read More
Many device manufacturers are guilty of engaging in practices that leave their software components open to computer attack, a software security professional said. Read More
An analysis of the FDA’s Emergency Use Authorization (EUA) process for COVID-19 diagnostic tests found that the lack of automation in the submission and tracking system hampered product reviews by the agency. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is introducing “innovative new routes to market” as it develops post-Brexit regulations for medical devices, according to attorneys at the London-based law firm Bristows. Read More
The European Commission (EC) announced yesterday that it is pushing back the compliance dates for the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) in light of the ongoing pandemic, to “prevent disruption in the supply of these essential healthcare products.” Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
Devices containing cobalt must meet new safety and performance requirements that went into effect Oct. 1 in the European Union, following a four-year review process. Read More
The FDA will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain Class I and unclassified devices starting Sept. 24, 2022, the agency said in a new draft guidance released yesterday. Read More